Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Signed informed consent,
• Male or female patients, 18 to 75 years of age,
• Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
• Active symptomatic and histological EoE
• Negative pregnancy test in females of childbearing potential at baseline visit.
Locations
United States
Arkansas
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Little Rock
Arizona
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Scottsdale
California
Dr. Falk Investigational Site
RECRUITING
La Jolla
Dr. Falk Investigational Site
WITHDRAWN
Lomita
Dr. Falk Investigational Site
NOT_YET_RECRUITING
San Diego
Florida
Dr. Falk Investigational Site
RECRUITING
Doral
Dr. Falk Investigational Site
NOT_YET_RECRUITING
New Port Richey
Idaho
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Boise
Louisiana
Dr. Falk Investigational Site
RECRUITING
Houma
Dr. Falk Investigational Site
RECRUITING
Marrero
Massachusetts
Dr. Falk Investigational Site
RECRUITING
Boston
Michigan
Wyoming
NOT_YET_RECRUITING
Ann Arbor
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Wyoming
Minnesota
Dr. Falk Investigational Site
RECRUITING
Rochester
North Carolina
Dr. Falk Investigational Site
RECRUITING
Chapel Hill
New Jersey
Dr. Falk Investigational Site
RECRUITING
Freehold
Dr. Falk Investigational Site
RECRUITING
Jackson
New York
Dr. Falk Investigational Site
NOT_YET_RECRUITING
New York
Ohio
Dr. Falk Investigational Site
RECRUITING
Cleveland
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Mentor
Pennsylvania
Wyoming
NOT_YET_RECRUITING
Philadelphia
Texas
Dr. Falk Investigational Site
RECRUITING
Harlingen
Utah
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Salt Lake City
Virginia
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Charlottesville
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Lynchburg
Other Locations
Spain
Department of Gastroenterology, Hospital General de Tomelloso
RECRUITING
Tomelloso
Contact Information
Primary
Sarah Burrack, Dr.
zentrale@drfalkpharma.de
004976115140
Time Frame
Start Date: 2021-05-21
Estimated Completion Date: 2027-03
Participants
Target number of participants: 308
Treatments
Experimental: Arm A
Budesonide 2 mg orodispersible tablet once daily
Active_comparator: Arm B
Budesonide 1 mg orodispersible tablet twice daily
Related Therapeutic Areas
Sponsors
Leads: Dr. Falk Pharma GmbH